Prime Medicine

Prime Medicine

VP, Regulatory Affairs

Cambridge, MA · Vp · Full-time

Sponsorship not specified$313k-$348kDetected 20 days ago
ComplianceNegotiationM&AFDA RegulatoryCRISPRResearchLeadershipCommunicationCollaborationMentoringRegulatory Affairs

Stay score

odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level IV · 4×
Level I$70,4501 entry
Level II$90,5422 entries
Level III$110,6353 entries
Level IV$130,7284 entries

This range already reaches Level IV — the maximum four lottery entries.

DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

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About the role

  • Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients.
  • Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung.
  • For more information, please visit www.primemedicine.com.

Responsibilities

  • Develop and own global regulatory strategies for all Prime Medicine programs, including gene editing (Prime Editing), cell therapy, pulmonary and combination product modalities
  • lead and manage high-stakes regulatory meetings, negotiations, and correspondences
  • Lead the development of regulatory risk assessments and mitigation strategies across all pipeline programs
  • Lead strategy and execution for Breakthrough Therapy, RMAT, Orphan Drug, and other expedited designation requests as applicable
  • Maintain a thorough understanding of evolving regulatory guidance for advanced medicinal therapy products (ATMPs), gene therapies, and gene-edited cell therapies
  • Team Building & Cross-Functional Collaboration

Requirements

  • Minimum 5+ years of leadership experience in a global regulatory affairs role, with demonstrated success managing teams
  • Demonstrated track record of successful IND and CTA submissions for novel modalities, including experience with CBER-regulated programs
  • Demonstrated track record of successful BLA, NDA, and/or MAA submissions, including driving regulatory strategy and critical submission activities within expedited timelines across US and international regions.
  • Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways is highly desirable
  • Exceptional strategic thinking with the ability to translate complex scientific and regulatory challenges into clear, actionable regulatory plans
  • Hands-on mentality, with ability to work in a very lean environment and willingness to generate regulatory content when necessary.
  • Comfort and experience managing contract research organizations.
  • US citizenship or valid work authorization required

Nice to have

  • Bachelor's degree in a scientific discipline required
  • and advanced degree (PhD, PharmD, or MD) strongly preferred
  • Minimum 15+ years of progressively responsible regulatory affairs or comparable experience in the pharmaceutical or biotechnology industry, gene/ cell/ novel platform therapy will be preferred
  • Significant experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products (ATMPs) is strongly preferred

Skills

  • Experience working in rare and orphan disease, and familiar with unique regulatory frameworks guiding development in this therapeutic area.

Compensation

  • $313,000 - $348,000 USD
  • Competitive base salary commensurate with experience
  • The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.

Benefits

  • Performance-based annual bonus eligibility
  • Equity participation (stock options) reflects our commitment to shared success
  • Comprehensive benefits package including medical, dental, vision, 401(k), and more
  • Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education.
  • This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).

Equal opportunity

  • Prime Medicine is proud to be an equal opportunity employer.
  • equal opportunity employer.

Visa & Work Authorization

  • US citizenship or valid work authorization required
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This listing is sourced directly from Prime Medicine's careers page and normalized into a canonical job model.